The present invention relates to a device and method for facilitating alignment of a medical instrument within the tubal ostia of the Fallopian tubes. As used herein, the term xe2x80x9cmedical instrumentxe2x80x9d includes a medical or surgical instrument.
There are various medical procedures that require doctors and surgeons to gain access to the Fallopian tubes by way of the transcervical, transvaginal access route into the uterus. Such medical procedures include patency testing of the Fallopian tubes, sterilization by tubal ligation or tubal occlusion, and fertilization procedures involving delivery of sperm into the Fallopian tubes. At the present time, several transcervical techniques are being developed to perform voluntary sterilization procedures by tubal occlusion using RF (radio frequency), microwave, implanted materials and chemical means. These transcervical sterilization techniques will replace surgical methods of sterilization, thereby allowing sterilizations to be performed more conveniently in doctors"" offices or clinics, rather than in hospitals. These transcervical techniques, however, do not include a means by which their respective medical instruments can be aligned with the tubal ostium to facilitate a successful procedure.
To successfully perform the aforesaid medical procedures, doctors and surgeons must be able to guide the necessary instruments through the vagina and cervix, into the uterus and to the tubal ostium, i.e., the intrauterine opening of the Fallopian tubes. The diameter of each Fallopian tube at the tubal ostium is typically less than 1.0 millimeter. Thus, the most difficult part of the aforesaid medical procedures is often aligning an instrument with the tubal ostium such that the instrument will properly enter the Fallopian tube. Alternatively, proper alignment with the tubal ostium is important in certain procedures to ensure that dye, medicine or sperm will be properly delivered directly into the Fallopian tube, minimizing waste and maximizing the effectiveness of the procedure. Moreover, if such an insertion is attempted and fails, the Fallopian tube will often go into spasm and make subsequent attempts at entry much more difficult. It is, therefore, important that entry into the Fallopian tube during these medical procedures is successful on the first attempt, which, in turn, requires proper alignment with the tubal ostium.
Various methods exist to facilitate the alignment of medical instruments with the tubal ostium. For example, one method involves the transvaginal, transcervical insertion of a hysteroscope into the uterus to allow the doctor to visually align the medical instruments with the tubal ostium. This method, however, requires additional visualization equipment that is expensive and, in many Third World countries, prohibitively expensive. In addition, this method requires training and a skill level that many gynecologists may not possess.
Alignment devices, fluid dispensing instruments, uterine access catheter systems and the like are known for use within the female reproductive system. For example, U.S. Pat. No. 6,080,129 to Blaisdell discloses a catheter system for the uterus having a sleeve slidably disposed over an inner catheter. Initial access to the uterus is accomplished by positioning the inner catheter through the cervix with the sleeve remaining outside of the cervix. After inflating a balloon near the distal end of the inner catheter, contact media can be injected and hysterosalpinogography is performed.
U.S. Pat. No. 4,182,328 to Bolduc et al. discloses a fluid dispensing instrument for placing a drug material into the canals of the Fallopian tubes of a female. The instrument includes a housing carrying a piston and cylinder assembly which is operable to expand a balloon at its distal end, as well as to dispense drugs into the uterine cavity above the partly expanded balloon. The instrument is fully expanded to move the drugs from the uterine cavity into the canals of the Fallopian tubes.
In view of the foregoing, it is an object of the present invention to provide an alignment device for use by medical practitioners in blind medical procedures wherein the medical instrument is aligned with the tubal ostium of each Fallopian tube to facilitate a successful medical procedure within the Fallopian tubes without the use of an hysteroscopic instrument. Such an alignment device lends itself to use by medical personnel who need not have a high level of proficiency.
Another object of the present invention is to provide an alignment device that allows easy access of appropriate medical instruments to both right and left tubal ostium for the bilateral access, evaluation and/or treatment of each Fallopian tube.
Another object of the present invention is to provide an alignment device that eliminates the use of current visualization techniques using expensive hysteroscopic hardware and procedures by the gynecologists to evaluate a reproductive problem of a female patient.
Another object of the present invention is to provide an alignment device that will assist in transcervical sterilization (tubal ligation of the Fallopian tubes through the cervix and vagina) in order to assure accurate entry into the Fallopian tubes via the tubal ostia or tubal ostium.
Another object of the present invention is to provide an alignment device that will allow tubal patency testing to be done in a doctor""s office without fluoroscopic procedures that irradiate the female patient and are normally performed in hospital settings.
Another object of the present invention is to provide an alignment device for use in Third World countries where fluoroscopic equipment and hysteroscopic visualization hardware may not be available.
Another object of the present invention is to provide an alignment device that will permit gynecologists, medical practitioners or trained clinic personnel to access the tubal ostia of the Fallopian tubes.
Another further object of the present invention is to provide an alignment device that is easy to use and is fully disposable after use.
A still further object of the present invention is to provide an alignment device that can be mass produced in an automated and economical manner and is readily affordable by the medical practitioner.
In accordance with the present invention, there is provided an alignment device adapted to deliver a medical instrument to an operating site within a body cavity. The alignment device includes a catheter member having an elongated body which is provided with a plurality of channels, at least one of the channels being sized and shaped so as to allow a medical instrument to pass through and at least another of the channels being sized and shaped so as to allow fluid to pass therethrough. The alignment device is also provided with an expandable member, which is expandable from a contracted state to an expanded state by fluid received from the catheter member. Guiding means, in the form of conduits, passageways, or the like, are located within the expandable member for guiding a medical instrument through the expandable member, when it is in its expanded state, to an operating site within a body cavity.